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Regulatory Affairs Specialist - Japanese Bilingual

Company: Freyr Solutions (Client: Pharmaceutical Company)
Location: Princeton
Posted on: September 22, 2022

Job Description:

_KEY RESPONSIBILITIES: _ Executes regulatory activities for team members or projects in accordance with applicable regulations and guidelines, under supervision. Prepares, reviews and releases routine submissions to INDs such as investigator updates, safety reports, annual reports and IND amendments, under supervision. Prepares submission cover letters and forms. Researches and assists in the preparation of general responses to FDA queries. Attends study team meetings and provides guidance on regulatory administrative and logistical issues. Assists with Agency meetings. Knowledgeable of submission requirements and completes Document Plans for regulatory submissions. Works with Regulatory Operations to ensure documents are in system; performs QC checks on published submissions to ensure completeness and compliance with company guidelines and FDA regulatory requirements. Schedules and manages meetings, accurately captures scientific discussion in minutes. _SKILLS REQUIRED: _ BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 5 to 10 years pharmaceutical/biopharma Regulatory experience including experience as an with international experience strongly preferred. Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Demonstrated leadership, problem-solving ability, flexibility, and teamwork. Good judgement in elevating and communicating actual or potential issues to line management. Excellent written and oral communication skills. Experience of active participation in Agency/Industry groups/forums expected. Flair for regulatory strategyJob Types: Full-time, Contract, TemporaryPay: $52,150.40 - $100,813.84 per yearBenefits: 401(k) matching Dental insurance Flexible spending account Health insurance Paid time off Parental leave Vision insuranceSchedule: 8 hour shiftExperience: Regulatory Affairs: 5 years (Required)Language: Japanese (Required)Work Location: Remote Speak with the employer

Keywords: Freyr Solutions (Client: Pharmaceutical Company), Trenton , Regulatory Affairs Specialist - Japanese Bilingual, Other , Princeton, New Jersey

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